The following data is part of a premarket notification filed by World Class Technology Corporation with the FDA for Clear21.
| Device ID | K192202 | 
| 510k Number | K192202 | 
| Device Name: | Clear21 | 
| Classification | Bracket, Ceramic, Orthodontic | 
| Applicant | World Class Technology Corporation 1300 NE Alpha Dr. Mcminnville, OR 97128 | 
| Contact | Alan Kozlowski | 
| Correspondent | Alyssa Thomas Allegiance Regulatory Consulting LLC 16642 SW Lansford Ct. Beaverton, OR 97007 | 
| Product Code | NJM | 
| CFR Regulation Number | 872.5470 [🔎] | 
| Decision | Substantially Equivalent (SESE) | 
| Type | Traditional | 
| 3rd Party Reviewed | No | 
| Combination Product | No | 
| Date Received | 2019-08-14 | 
| Decision Date | 2019-11-12 | 
| Mark Image Registration | Serial | Company Trademark Application Date | 
|---|---|
|  CLEAR21  88318941  not registered Live/Pending | World Class Technology Corporation 2019-02-27 |